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A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

albiglutide

liraglutide

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GSK716155, liraglutide, albiglutide, open-label

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
BMI >/=20kg/m2 and </=45 kg/m2
Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
HbA1c between 7.0% and 10.0%, inclusive
Female subjects of childbearing potential must be practicing adequate contraception.

Exclusion Criteria:

History of cancer
History of treated diabetic gastroparesis
Current biliary disease or history of pancreatitis
History of significant GI surgery
Recent clinically significant cardiovascular and/or cerebrovascular disease
Hypertension
History of human immunodeficiency virus infection
History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
History of alcohol or substance abuse
Female subject is pregnant, lactating, or <6 weeks postpartum
Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
History of type 1 diabetes mellitus
Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
History or family history of thyroid disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

albiglutide

liraglutide

Arm Description

weekly albiglutide subcutaneous injection

liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

Secondary Outcome Measures

Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

Time to Hyperglycemia Rescue at Week 32

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.

Mean Change From Baseline in Body Weight at Week 32

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.

Full Information

NCT ID

NCT01128894

First Posted

April 29, 2010

Last Updated

January 9, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01128894

Brief Title

A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Official Title

A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Detailed Description

This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

GSK716155, liraglutide, albiglutide, open-label

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

841 (Actual)

8. Arms, Groups, and Interventions

Arm Title

albiglutide

Arm Type

Experimental

Arm Description

weekly albiglutide subcutaneous injection

Arm Title

liraglutide

Arm Type

Active Comparator

Arm Description

liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Intervention Type

Biological

Intervention Name(s)

albiglutide

Intervention Description

albiglutide weekly subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

Description

Time Frame

Baseline and Week 32

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

Description

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

Time Frame

Baseline, Weeks 4, 6, 12, 18 and 26

Title

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

Description

Time Frame

Baseline and Week 32

Title

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Description

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Title

Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

Description

Time Frame

Week 32

Title

Time to Hyperglycemia Rescue at Week 32

Description

Time Frame

Week 32

Title

Mean Change From Baseline in Body Weight at Week 32

Description

Time Frame

Baseline and Week 32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications BMI >/=20kg/m2 and </=45 kg/m2 Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L) HbA1c between 7.0% and 10.0%, inclusive Female subjects of childbearing potential must be practicing adequate contraception. Exclusion Criteria: History of cancer History of treated diabetic gastroparesis Current biliary disease or history of pancreatitis History of significant GI surgery Recent clinically significant cardiovascular and/or cerebrovascular disease Hypertension History of human immunodeficiency virus infection History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C History of alcohol or substance abuse Female subject is pregnant, lactating, or <6 weeks postpartum Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast History of type 1 diabetes mellitus Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide) Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies History or family history of thyroid disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

GSK Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

GSK Investigational Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85295

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

GSK Investigational Site

City

Searcy

State/Province

Arkansas

ZIP/Postal Code

72143

Country

United States

Facility Name

GSK Investigational Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

GSK Investigational Site

City

Escondido

State/Province

California

ZIP/Postal Code

92026

Country

United States

Facility Name

GSK Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

GSK Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

GSK Investigational Site

City

Indio

State/Province

California

ZIP/Postal Code

92201

Country

United States

Facility Name

GSK Investigational Site

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

GSK Investigational Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

GSK Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

GSK Investigational Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92128

Country

United States

Facility Name

GSK Investigational Site

City

Satna Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

GSK Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

GSK Investigational Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

GSK Investigational Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

GSK Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

GSK Investigational Site

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

GSK Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

GSK Investigational Site

City

Cocoa

State/Province

Florida

ZIP/Postal Code

32927

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

GSK Investigational Site

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

GSK Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32822

Country

United States

Facility Name

GSK Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

GSK Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

GSK Investigational Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

GSK Investigational Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32792

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

GSK Investigational Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

GSK Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

GSK Investigational Site

City

Stone Mountain

State/Province

Georgia

ZIP/Postal Code

30088

Country

United States

Facility Name

GSK Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

GSK Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

GSK Investigational Site

City

La Grange

State/Province

Illinois

ZIP/Postal Code

60525

Country

United States

Facility Name

GSK Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

GSK Investigational Site

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

GSK Investigational Site

City

Council Bluffs

State/Province

Iowa

ZIP/Postal Code

51501

Country

United States

Facility Name

GSK Investigational Site

City

Dubuque

State/Province

Iowa

ZIP/Postal Code

52001

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

GSK Investigational Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

GSK Investigational Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

GSK Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

GSK Investigational Site

City

Haverhill

State/Province

Massachusetts

ZIP/Postal Code

01830

Country

United States

Facility Name

GSK Investigational Site

City

Bloomfield Hills

State/Province

Michigan

ZIP/Postal Code

48302

Country

United States

Facility Name

GSK Investigational Site

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48235

Country

United States

Facility Name

GSK Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

GSK Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

GSK Investigational Site

City

St Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55430

Country

United States

Facility Name

GSK Investigational Site

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

GSK Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

GSK Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

GSK Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89103

Country

United States

Facility Name

GSK Investigational Site

City

Elizabeth

State/Province

New Jersey

ZIP/Postal Code

07202

Country

United States

Facility Name

GSK Investigational Site

City

Haddon Heights

State/Province

New Jersey

ZIP/Postal Code

08035

Country

United States

Facility Name

GSK Investigational Site

City

North Massapequa

State/Province

New York

ZIP/Postal Code

11758

Country

United States

Facility Name

GSK Investigational Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10301

Country

United States

Facility Name

GSK Investigational Site

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

GSK Investigational Site

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645

Country

United States

Facility Name

GSK Investigational Site

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

GSK Investigational Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Canal Fulton

State/Province

Ohio

ZIP/Postal Code

44614

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

GSK Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

GSK Investigational Site

City

Gallipolis

State/Province

Ohio

ZIP/Postal Code

45631

Country

United States

Facility Name

GSK Investigational Site

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

GSK Investigational Site

City

Downington

State/Province

Pennsylvania

ZIP/Postal Code

19335

Country

United States

Facility Name

GSK Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

GSK Investigational Site

City

Murrells Inlet

State/Province

South Carolina

ZIP/Postal Code

29576

Country

United States

Facility Name

GSK Investigational Site

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

GSK Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

GSK Investigational Site

City

Clarksville

State/Province

Tennessee

ZIP/Postal Code

37043

Country

United States

Facility Name

GSK Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38125

Country

United States

Facility Name

GSK Investigational Site

City

Tullahoma

State/Province

Tennessee

ZIP/Postal Code

37398

Country

United States

Facility Name

GSK Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

GSK Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77036

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77088

Country

United States

Facility Name

GSK Investigational Site

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

Facility Name

GSK Investigational Site

City

Katy

State/Province

Texas

ZIP/Postal Code

77450

Country

United States

Facility Name

GSK Investigational Site

City

Midland

State/Province

Texas

ZIP/Postal Code

79707

Country

United States

Facility Name

GSK Investigational Site

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78237

Country

United States

Facility Name

GSK Investigational Site

City

Schertz

State/Province

Texas

ZIP/Postal Code

78154

Country

United States

Facility Name

GSK Investigational Site

City

Sugarland

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

GSK Investigational Site

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

GSK Investigational Site

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

GSK Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

GSK Investigational Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

GSK Investigational Site

City

Burke

State/Province

Virginia

ZIP/Postal Code

22015

Country

United States

Facility Name

GSK Investigational Site

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

GSK Investigational Site

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

GSK Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

GSK Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99216

Country

United States

Facility Name

GSK Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

GSK Investigational Site

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

GSK Investigational Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

GSK Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

GSK Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

GSK Investigational Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

GSK Investigational Site

City

Ringwood East

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

GSK Investigational Site

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

GSK Investigational Site

City

Beer-Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

35251

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

GSK Investigational Site

City

Goyang

ZIP/Postal Code

414410

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seongnam-si,

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seongnam-si

ZIP/Postal Code

463712

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135720

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

139-872

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Callao

State/Province

Lima

ZIP/Postal Code

Callao 2

Country

Peru

Facility Name

GSK Investigational Site

City

Huacho

State/Province

Lima

Country

Peru

Facility Name

GSK Investigational Site

City

Ica

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 1

Country

Peru

Facility Name

GSK Investigational Site

City

Piura

Country

Peru

Facility Name

GSK Investigational Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

GSK Investigational Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

GSK Investigational Site

City

Makati City

ZIP/Postal Code

1218

Country

Philippines

Facility Name

GSK Investigational Site

City

Marikina City

ZIP/Postal Code

1810

Country

Philippines

Facility Name

GSK Investigational Site

City

Pasay

ZIP/Postal Code

1300

Country

Philippines

Facility Name

GSK Investigational Site

City

Pasig City

ZIP/Postal Code

1600

Country

Philippines

Facility Name

GSK Investigational Site

City

Pasig

ZIP/Postal Code

1600

Country

Philippines

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03114

Country

Spain

Facility Name

GSK Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda (Madrid)

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Modulo H

ZIP/Postal Code

07120

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

Torrevieja (Alicante)

ZIP/Postal Code

03186

Country

Spain

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Hertfordshire

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Livingston

ZIP/Postal Code

EH54 6PP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swansea

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

24703047

Citation

Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6. Erratum In: Lancet Diabetes Endocrinol. 2014 Mar;2(3):e5.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

114179

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

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A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial